The challenge of biosimilars

Biosimilares/Investigación | Posted 05/08/2009 post-comment0 Post your comment

In a study by Professor Håkan Mellstedt of the Karolinska University Hospital Solna, Stockholm, Sweden, Professor Dietger Niederwieser of the University of Leipzig, Germany, and Heinz Ludwig of the Wilhelminenspital, Vienna, Austria – who all served as ad hoc scientific advisors to Amgen – issues associated with the introduction of alternative versions of biosimilars used in the oncology setting were reviewed.

Data were obtained by searches of Medline, PubMed, references from relevant English-language articles, and guidelines from the EMEA.

They found that when biosimilars are approved in EU, they will be considered ‘comparable’ to the reference product, but this does not ensure therapeutic equivalence. Inherent differences between biosimilars may produce dissimilarities in clinical efficacy, safety, and immunogenicity. Switching biosimilars should be considered a change in clinical management. Regulatory guidelines have been established for some biosimilar categories but, because of the limited clinical experience with biosimilars at approval, pharmacovigilance programmes will be important to establish clinical databases. Guidelines also provide a mechanism for the extrapolation of clinical indications (approved indications for which the biosimilar has not been studied). This may be of concern where differences in biological activity can result in adverse outcomes or when safety is paramount, e.g. stem cell mobilisation in healthy donors. These issues should be addressed in biosimilar labelling.

They concluded that biosimilars should provide cost savings and greater accessibility to biopharmaceuticals. A thorough knowledge surrounding biosimilars will ensure the appropriate use of biopharmaceuticals. Information is the key to mitigating the potential concerns regarding the use of biosimilars. In particular, physicians and pharmacists must be fully aware of the differences between biosimilars and innovator biopharmaceuticals. For complex biopharmaceutical agents, any change from one product to another (innovator to biosimilar or vice versa) should be considered a change in clinical management.

Source: Mellstedt H et al. The challenge of biosimilars. Ann Oncol. 2007:1-9. doi:10.1093/annonc/mdm345.

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